- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00814528
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
September 7, 2018 updated by: University of Chicago
The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-95 years old
- Diagnosied with actinic keratoses.
Exclusion Criteria:
- Patients who have had Isotretinoin therapy less that 1 year prior to screening.
- Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
- History of porphyria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).
|
20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes.
Topical ALA will be applied liberally on skin with extra pressure on lesions.
Incubation of ALA will take place for 0-3 hours.
Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes.
Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.
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Experimental: 2
5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.
|
Cryotherapy will be performed on lesions only every 2 week intervals.
Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks.
5-FU will be once daily on the treated areas 4- 6 weeks.
Responses will be monitored every 2 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Actinic keratosis /incomplete therapy and reoccurence
Time Frame: 18 months
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18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema
Time Frame: 2 weeks post therapy
|
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
|
2 weeks post therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 23, 2008
First Submitted That Met QC Criteria
December 23, 2008
First Posted (Estimate)
December 25, 2008
Study Record Updates
Last Update Posted (Actual)
September 10, 2018
Last Update Submitted That Met QC Criteria
September 7, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15725A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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